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Methotrexate 2.5 Mg 100 Tablets ingredient Methotrexate
METHOTREXAT "EBEWE" 2,5 mg tablet
It is administered orally.
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Active ingredient: Each tablet contains 2.5 mg methotrexate.
Adjuncts: Lactose monohydrate, corn starch, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide
You should read this USE INSTRUCTION carefully before you start using this medicine, because it contains important information for you.
• Save these instructions for use. You can need to read again.
• If you have any further questions, please consult your doctor or pharmacist.
This medication has been prescribed for you personally and you should not give it to anyone else.
When using this medicine, tell your doctor or doctor if you go to the hospital.
We sleep exactly as written in this instruction. Do not use high or low doses other than the recommended dose for your medication.
In this Instructions for Use:
1 METHOTREXAT What is "EBEWE" and what is it used for?
2. Things to consider before using METHOTREXAT "EBEWE"
3. How to use METHOTREXAT "EBEWE"?
4. What are the possible side effects?
5. Hiding METHOTREXAT "EBEWE"
Their headlines are in place.
1. What is METHOTREXAT "EBEWE" and what is it used for?
METHOTREXAT "EBEWE" is a yellow, round, notched face with a notched tablet (stains from methotrexate can be seen from yellow to red).
It is packed in a box containing 1 or 50 or 100 tablets in a plastic (polypropylene) bottle. METHOTREXAT "EBEWE" is a drug called antimetabolite, which prevents the proliferation of tumor cells.
METHOTREXAT "EBEWE" is used in the treatment of joint inflammation (rheumatoid arthritis) in adults.
METHOTREXAT "EBEWE" is used to treat serious, uncontrollable psoriasis (psoriasis) that does not respond to other treatments.
METHOTREXAT "EBEWE" is used alone or in combination with other cancer drugs in the treatment of various types of cancer:
Blood cancer (acute leukemia),
Lymph cancer (Non-Hodgkin's lymphoma),
Soft tissue and bone tumor (osteogenic sarcoma),
Breast, lung, head and neck, bladder, cervical, over and testicular cancers
2. Things to consider before using METHOTREXAT "EBEWE"
METHOTREXAT DO NOT USE "EBEWE" in the following situations
If you are allergic to the components of methotrexate or METHOTREXAT "EBEWE"
If you have serious liver disease (such as cirrhosis, active liver inflammation due to viruses, recent or active jaundice)
If there is visible jaundice
If you are consuming extreme alcohol
If you have serious kidney disease (such as those requiring kidney dialysis)
If you have serious blood disease (such as anemia at significant levels, a decrease in the number of your blood cells)
If you have immunodeficiency
If you have a serious infection (such as tuberculosis, HIV)
If you have oral cavity ulcers and known gastro-intestinal ulcers (wound)
You are pregnant and breastfeeding
In cases where live vaccinations (eg tuberculosis, measles, varicella vaccination) should be used at the same time
METHOTREXAT "EBEWE" USE ATTENTION WHEN
If you have bone marrow dysfunction
If you are older or your general health condition is bad
If you have liver disease
If you have had liver disease in the past, especially because of alcohol
If you are using other medications that may be liver damage together
If you have mild or moderate kidney disease
If you are using medications that are potentially harmful to the kidneys, such as other medications used in the treatment of rheumatism
If you have blood diseases or anemia
If you have nausea, diarrhea or stomach-intestinal discomfort
If you have blood vomit, your stool is black or you have blood in your stomach
If you have mental disorder or have been before
If you have received or receive radiation therapy
If you have symptoms of infection
If your body has excess fluid buildup (swelling in the lung or skin)
If excessive water loss (dehydration) is detected
If you have diabetes treated with insulin
Recommended control examinations and protective measures:
METHOTREXAT "EBEWE" can cause serious side effects even when used at low doses. Your doctor will check you on time to determine these and will require laboratory tests.
When the treatment starts again before or after the treatment has been interrupted:
Before treatment begins, your blood will be taken for some tests and the whole blood count will be checked for serum protein (serum albumin) to check your liver and kidney function.
Your doctor will ask for a chest x-ray for lung control and check your lymph nodes (neck, underarm and groin) by physical examination.
During treatment (once every two weeks for the first two weeks, then once every two weeks for one month, then for leukocyte (white blood cell count) and at least once a month for the first six months and at least every three months thereafter)
Increasing the frequency of control examinations should be considered in dose increments. In particular, elderly patients should be monitored briefly for the supervision of early signs of harmful effects.
Examination of oral cavity and your throat
In case of long-term treatment, bone marrow biopsy (bone marrow sampling with a special needle) can be performed if necessary.
Monitoring your liver function (if you have a steady increase in your liver-related enzymes measured in your blood, and / or if there is a decrease in the type of protein in your blood, you might consider dropping your medication dose or ending your treatment)
Monitoring your kidney function (examining your blood and / or urine to lower your medication dose or terminate your treatment)
Examination of the respiratory tract and, if necessary, performing lung function tests. Symptoms associated with lungs during treatment with methotrexate (especially dry, unswept coughing) or nonspecific pulmonary inflammation may be a sign of a potentially dangerous abnormal tissue. In this case, careful observation may be required by interrupting the treatment. If you have a persistent cough or shortness of breath to get information about the risks of lung inflammation, you should immediately contact your doctor.
Patients receiving METHOTREXAT "EBEWE" may develop malignant lymph nodes; in such a case your treatment will be terminated. If these lymph nodes do not self-tension, treatment of cancer needs to be initiated.
If you have abdominal cavity or fluid collection on your chest, the fluid should be drained before your treatment or your treatment should be stopped.
If you have conditions that result in excessive water loss, such as vomiting, diarrhea or intra-oral inflammation, the harmful effects of the medication may increase with increasing amounts of medication. In this case, your treatment should be stopped until the symptoms disappear.
Methotrexate levels should be determined within the first 48 hours after methotrexate administration as there may be harmful effects that can not be recycled.
Your gastro-intestinal tract should be stopped if there is any negative symptoms that may first appear with diarrhea and intra-oral inflammation. Otherwise, continued treatment may lead to inflammatory bowel inflammation and death, which is caused by intestinal perforation. If you have blood vomiting, your stool is black or if you have blood in your stomach, your treatment should be stopped.
During methotrexate therapy, eczema and sunburn can occur again as a result of previously treated radiation therapy. Combined treatment of radiation with methotrexate may lead to worsening of skin rashes. Concomitant administration of methotrexate with radiation therapy may increase the risk of damage to soft tissue and bone tissue.
Since some brain tissue diseases (encephalopathy / leukoencephalopathy) have been observed in cancer patients treated with methotrexate, it can not be ruled out that they are also seen in patients treated for non-cancer diseases.
High doses may cause methotrexate or its metabolites to precipitate in your kidney ducts. As a precautionary method, your doctor may recommend the administration of drugs such as sodium bicarbonate or acetazolamide, either orally or via a vein, to provide a high amount of urine output by administering liquids.
Men treated with methotrexate are advised not to be fathers during treatment and within 6 months of treatment. Because methotrexate treatment can cause severe illness in spermatogenesis, it is recommended that men receive medical support for possible sperm protection before treatment.
In women of childbearing age, taking methotrexate should be avoided if there is a possibility of pregnancy by making appropriate tests such as pregnancy test before the treatment starts.
Women with childbearing potential must have effective contraception during treatment (and up to 6 months after treatment). Methotrexate has been shown to have adverse effects on the baby in the womb, which can lead to miscarriages and / or birth defects. In patients with methotrexate cut off before pregnancy, normal pregnancy developed.
Please consult your doctor if these warnings apply to you, even at any time in the past.
Use of METHOTREXAT "EBEWE" with food and beverage
Do not take alcohol during METHOTREXAT "EBEWE" treatment and avoid excessive coffee
If you notice that you are pregnant during your treatment, consult your doctor or pharmacist immediately.
Consult your doctor or pharmacist before using this medication.
Experimental animals have been shown to pass the test.
Do not use METHOTREXAT "EBEWE" during breastfeeding.
With METHOTREXAT "EBEWE", breastfeeding should be stopped during treatment.
Vehicle and machine use
Depending on possible adverse effects such as dizziness or fatigue, METHOTREXAT "EBEWE" may disturb your ability to drive and use the machine. In such cases, do not use tools and machinery.
Important information about some of the auxiliary substances contained in METHOTREXAT "EBEWE"
METHOTREXAT "EBEWE" tablet contains lactose monohydrate as adjuvant. If you have previously been told by your doctor that you are not well tolerated with certain sugars, you should consult your doctor before taking this medicinal product.
Use with other medicines
The use of METHOTREXAT "EBEWE" with some medicines may impair the effectiveness of the treatment;
Drugs that damage liver or blood count (eg leflunomide)
Azathioprine (sometimes agents that suppress the immune system used in severe forms of arthritis)
Retinoids (drugs used for psoriasis and other skin diseases)
Antibiotics (drugs used to prevent certain infections / treat infections). Antibiotics such as tetracyclines, chloramphenicol and non-absorbable broad spectrum antibiotics, penicillins, glycopeptides, sulfonamides (sulphide containing drugs used to prevent certain infections / infections), ciprofloxacin and cephalothin)
Some drugs used in the treatment of pain and / or inflammation, known as non-steroidal anti-inflammatory drugs (eg pyrazoles such as salicylates such as ibuprofen, acetylsalicylic acid, and metamizole)
Probenecid, sulphinpyrazone (drugs used in the treatment of gout)
Drugs that increase urinary excretion (furosemide, triamteien etc.)
sedative drugs (pentobarbital, etc.)
Oral oral contraceptives (ethinyl estradiol, progesterone levonorgestrel, etc.)
Trimetoprim-sulfomethaxazole (antibiotics containing co-trimoxazole), drugs that cause undesirable effects on bone marrow such as pyrimethamine
Anti-rheumatic drugs (eg sulfasalazine)
Drugs used in the treatment of stomach diseases (eg proton pump inhibitors such as omeprazole or pantoprazole)
Folic acid-containing medicines or vitamin medicines containing folic acid or the like (unless your doctor has given them to reduce side effects)
Live vaccinations (eg BCG, measles, water blooms)
Drugs used in Sara's disease (eg diphenylhydantoin, phenytoin)
Drugs used to lower blood sugar (such as metformin)
P-aminobenzoic acid (used in the treatment of skin diseases)
Nitrous oxide (used during anesthesia)
Drugs used in the treatment of cholesterol (eg cholestyramine)
Drugs used in cancer treatment (eg 5-fluorouracil, mercaptopurine)
Simultaneous beam therapy
Theophylline (medicine used for bronchial asthma and other lung diseases)
Cyclosporine (a drug used to accept the transplanted body after organ transplants)
Please inform your doctor or pharmacist if you are using or have recently used any medicine with or without a prescription.
3. How to use METHOTREXAT "EBEWE"?
Instructions for proper use and dose / application frequency:
It is administered orally.
METHOTREXAT "EBEWE" Eat 1 hour before meals or 1.5-2 hours with a glass of water. Do not chew on your tablets.
METHOTREXAT "EBEWE" should be used once a week.
Application path and method:
You should always use METHOTREXAT "EBEWE" the way your doctor recommends to you. If you are unsure, consult your doctor or pharmacist.
Your doctor will tell you how often METHOTREXAT "EBEWE" is administered and how long your treatment will last, depending on your illness.
In the treatment of joint inflammation (rheumatoid arthritis):
Your tablets are usually taken once a week, 7.5 mg once daily or 2.5 mg three times daily (every 12 hours). The weekly dose may range from 7.5 mg to 20 mg depending on the response to treatment. If you take it every day, it causes very serious harmful effects.
Treatment of psoriasis (psoriasis):
The recommended dose is 10-25 mg once a week. Dosage will be adjusted by your doctor according to your response to the disease and your general health condition.
Your doctor can make 5-10 mg trial doses of the vagina to see the side effects of your medicine before the treatment begins.
METHOTREXAT "EBEWE" is usually given in a single daily dose not exceeding 5 consecutive days and each dose not exceeding 30 mg per m2 of surface area of your body. In order for your bone marrow to return to normal functioning of your blood cells, it is advisable to leave a period of at least two weeks without medication between your treatments.
Different age groups:
Use in children:
METHOTREXAT "EBEWE" has not been proven to be safe and effective in children.
Use in the elderly:
Your doctor will make the necessary dosage adjustments.
Special use cases:
Methotrexate should be used with caution in patients with poor renal function. If you have kidney failure, your doctor will make the necessary dosage adjustments.
Methotrexate should be used with caution in patients who have had or are suffering from serious liver disease, particularly alcohol. If you have liver impairment, your doctor will make the necessary dosage adjustments.
If you have an impression that the effect of METHOTREXAT "EBEWE" is too strong or weak, talk to your doctor or pharmacist.
If you use more METHOTREXAT "EBEWE" than you need:
Inform your doctor or go to the nearest hospital. Whether the methotrexate tablet is left or not, take the box of your medicine.
METHOTREXAT "EBEWE" If you have used too much, talk to a doctor or pharmacist.
If you forget to use METHOTREXAT "EBEWE"
If you forget to take METHOTREXAT "EBEWE", consult your doctor or pharmacist before taking the medicine again as soon as you remember. If you have forgotten more than two doses a day, consult your doctor.
Do not take double doses to compensate for forgotten doses.
Effects that may occur when treatment with METHOTREXAT "EBEWE" is terminated
Stopping METHOTREXAT "EBEWE" treatment without your doctor's approval may cause your illness to get worse. Do not end treatment without your doctor's approval.
4. What are the possible side effects?
As with all medicines, there may be side effects in people who are sensitive to substances in the content of METHOTREXAT "EBEWE".
The most common side effects include oral inflammation, decreased white blood cell count, nausea and abdominal pain. Very rarely, life-threatening allergic reactions to methotrexate swelling of the hives, hands, feet, face, lips, mouth, or throat (swelling of the mouth and lips may cause difficulty swallowing or breathing), wheezing and feelings of passion. Other reported side effects are decreased resistance to eye irritation, fatigue, excessive fatigue, vascular inflammation, blood poisoning, joint pain / muscle aches, tremors and fever, dizziness, decreased sexual desire / impotence and infection. Opportunistic infections (sometimes fatal blood poisoning) have been reported in patients receiving methotrexate for cancer and non-cancerous diseases, most commonly a particular type of lung inflammation (Pneumocystis carinii, a mantle-associated lung inflammation). Other reported infections include diseases of the lungs (nocardiosis, histoplasmosis, cryptococcosis) caused by viruses, fungi and bacteria, bacterial and fungal infections, shingles (a rash and painful disease caused by herpes zoster virus), petechiae, The infection (including cytomegalovirus-induced lung inflammation) is caused by the virus (cytomegalovirus)
Possible side effects are listed by the following categories.
Very common: it can be seen in at least 1 of 10 patients.
Common: less than one in 10 patients, but more than one in 100 patients.
Uncommon: less than one in 100 patients, but more than one in 1000 patients.
Rare: less than one in 1000 patients, but more than one in 10,000 patients.
Very rare: less than one in 10,000 patients.
Unknown: It can not be predicted by moving from the available data.
Loss of appetite
Wounds on the inner surface of the mouth (ulcer)
Increase in liver enzyme levels
Decrease in the number of blood cells (white / red blood cells or blood pulses)
Lung infection, unwanted effects caused by lung infection and consequential deaths. Typical symptoms include general illness, dry and unwholesome cough, sometimes severe respiratory distress to resting breathing, chest pain and fever.
Derive rash, redness, itching
Lymph cancer formation (not fully proven)
Decrease in the numbers of all blood cells and the number of blood pulses (cells that provide blood clotting)
Sudden decrease of white blood cells in the body (agranulocytosis)
disorders in blood cell formation (hematopoietic disorders)
Allergic reactions, shock, fever, trembling affecting the whole body
Depression (mental disorder)
involuntary muscle contractions,
Formation of connective tissue such that respiratory and breathing functions in the normal tissue of the lung may be impaired
Gastro-intestinal wounds (ulcers) and bleeding
General fatigue, muscle weakness, loss of appetite, nausea and vomiting, pain and tenderness in the upper left corner of the abdomen, itching, jaundice, increased tendency to bleeding and rotting, hair loss, chills and sweating, edema in the lower limbs, liver cirrhosis, hepatic steatosis (despite normal values of liver-associated enzymes at regular intervals)
Decrease in the amount of albumin present
Sensitivity to light
Deride color change
Shingles disease (a rash and painful disease caused by herpes zoster virus)
Wound healing impairment
Increase in rheumatoid nodules
If you have psoriasis; wounds due to skin ulcers and sunlight exposure
Inflammation of the vasculature, itching and rash (herpetiform skin rash), redness in skin, mouth, genital organs, inflammation, severe rash, blistering and fever
Muscle and joint pain
Reduction in bone mass (osteoporosis)
Bladder inflammation and ulcer (probably bloody urine)
Vaginal inflammation and ulcers
Malignant red cell deficiency (megaloblastic anemia)
Mild transient memory, attention and perception impairment
Severe visual disturbances
In the case of fluid accumulation in the outer membrane of the heart, the pressure of the heart under pressure (pericardial tamponade)
fluid accumulation in the outer membrane of the heart (pericardial effusion)
Cardiac inflammation (pericarditis)
Low blood pressure, state of clotting in the deep veins of the body (thromboembolic events including arterial and cerebral thrombosis, thrombophlebitis, deep vein thrombosis of the leg, retinal vein thrombosis, pulmonary embolism)
bronchial asthma-like reactions such as throat infection, respiratory paralysis, cough, changes in the disease related to breathlessness and pulmonary function test
inflammation of the small intestine (enteritis)
Black stool due to gastrointestinal bleeding
Absorption in the intestines
Hepatitis and liver damage from new fruit.
Increase of color change in nails
The nail partially or wholly plays from the bed
A skin disease (acne) related to the face, shoulders, back and abdomen sebaceous glands
Skin rashes in the lower limb (petechia, ecchymosis)
Stress fracture (small cracks in the bones after overuse)
Lack of urine, incontinence
abnormal increase of nitrogen containing compounds (azoemia)
Decrease in sperm count
Detection of persistent microorganisms and their toxic substances (sepsis)
Various infections caused by bacteria (opportunistic infections (viruses and fungal diseases) that can result in death in some cases)
The condition in which the bone marrow can not produce as many or as few new cells (applica- tive anemia)
Lymph node enlargement (lymphadenopathy)
Immune system disorders (partially reversible lymphoproliferative disorder)
Detection of normal white blood cells (eosinophilia)
The number of low white cells in the vicinity (neutropenia)
Suppression of the immune system
Decrease in the number of Kanda antibodies (defenses brought by the body against the foreign substances entering the body)
Vascular inflammation (severe symptom) with narrowing of the veins, damage on the wall and thickening pain, edema, redness, temperature increase and wound (ulcer) formation and / or dysfunction in the fed tissues and organs fed,
Sensory disorders such as numbness, tingling or burning sensation
Taste changes (metallic taste)
Meningitis is a type of meningitis (acute aseptic meningitis) with similar febrile illness (paralysis, vomiting)
Destruction of retinal vessels in the eye (retinopathy)
Pneumocystis carinii (one bacterial) infection and other lung infections
chronic respiratory disease (chronic obstructive pulmonary disease) leading to progressive dyspnea
Fluid accumulation in the chest membrane
Swelling in the intestine (toxic megacolon)
Reactivating chronic inflammation of<